K150606

Substantially Equivalent

Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: DJG
Advisory panel: Clinical Toxicology
Date received: 2015-03-10
Decision date: 2015-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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